Vistin Pharma : Presentation 2021

Presentation

2021

A leading global dedicated supplier of Metformin

• High Quality Premium manufacturer with ~10% global market share
• • Dedicated & fully automated manufacturing site in Norway with 3500 MT Metformin API capacity
  • Ongoing expansion project doubling capacity to 7000MT during 2022
  • >60 years experience in Metformin manufacturing
  • Long term collaboration and sales to global multinational pharmaceutical companies
  • Certified by all significant international regulatory bodies

• Products offered
• • Metformin HCl (bulk API)
  • Metformin DC (directly compressible granules)
  • Metformin HCl with specific particle size distribution (PSD)
  • Metformin HCl with lubricants (Premix)
• Unique offering
• • High delivery performance (>98%), on time in full
  • Best free-flowing API on the market
  • Customized Particle Size Distribution
  • All shipments according to GDP (Good Distribution Practice)
  • Flexible customer solutions and excellent customer service
  • Strong focus on Environment, Social and Health (ESG)
  • API with no detectable content of nitrosamine
  • Low levels of residual DMA, impurity f

Product range & Capacities

Product	Pack & batch size	Annual capacity	Regulatory compliance
Metformin HCl	Pack size: 25 kg carton	~3500 MT	Ph.Eur. (CEP), USP, JP and BP
Active Pharmaceutical Ingredient	(Big-bag available on request)		US DMF
		Additional capacity	- LoA to US DMF available on request
	Batch size: ~3100 kg	from 2022 +3500 MT
Metformin DC	Pack size: 25 kg carton	~800 MT	US DMF
- Direct Compressible lubricated granules,	(Big-bag available on request)	Additional capacity	- LoA to US DMF available on request
92,6%		from 2022 +800 MT
	Batch size: ~800 kg

Regulatory Compliance

• Regulatory Status
• • GMP Certificate for covering manufacturing of Metformin HCl (API) and Metformin DC (drug product intermediate)
  • Certificate of Suitability to the European Pharmacopoeia (CEP)
  • API in compliance with current Ph.Eur., USP and JP monographs
  • US DMF filed for Metformin HCl and DC
  • Other DMFs filed in Japan, Korea, Brazil, China and more
  • Letter of Authorization to DMF available on request

• Latest authority inspections at Vistin Pharma

Norwegian Medicines Agency (NoMA) 2018. (Audit closed)

US Food and Drug Administration (FDA), 2019. 2 Form 483 observations. (Audit closed)

PMDA "paper audit", 2019. (Approved)

Korean Food and Drug Administration (KFDA), 2012

Brazilian Health Authorities (ANVISA), 2011

Business update Vistin Pharma

2019

2020	Nitrosamines

Covid-19

• Successful installation of new fully automatic packaging line.
• High demand for Vistin's volume, sold out in 2019, 2020 and 2021

• In April our board approved an investment to double our manufacturing capacity
• First step of our expansion project successfully implemented with a new duplicated reactor in week 41
• Finalization of our expansion project in Q2 2022 will double our capacity to ~7000 MT

• Based on risk assessment and current available data (approx. 230 batches tested in-house, and more than 700 batches tested by customers):
• No detectable content of NDMA present in our Metformin HCl
• No routine testing is required for controlling levels of Nitrosamines in Vistin Pharma API
• Vistin's Metformin HCl has low levels of residual DMA (impurity F) which is relevant factor for limiting NDMA formation in formulated drug products.

• No interruption in production due to raw material supply
• No employee affected
• Vistin is experiencing increased demand for European based supply of quality Metformin HCl